Program is subject to change.
PRE-RECORDED LECTURES
Novel Trial Designs
Leveraging Large Datasets in Clinical Trial Design
Workshop Pretest
Completed online between Saturday, July 22 and Sunday, July 23
SUNDAY, JULY 23
Registration
1:30 pm-5:30 pm
Faculty Meeting
4:30 pm-5:15 pm
Welcome/Overview
5:30 pm-5:45 pm
Opening Keynote Lecture
5:45 pm-6:30 pm
Dinner
6:30 pm-7:15 pm
Protocol Development Group Session
7:30 pm-9:00 pm
MONDAY, JULY 24
Breakfast
7:00 am-8:00 am
Lecture Session 1
8:00 am-10:00 am
- Clinical Trial Design: Asking Important Questions that Impact Our Patients
- Answering Important Questions: From Hypothesis to Analysis
- Phase I Trial Questions
- Phase I Trial Designs
Questions / Panel Discussion
Break
10:00 am-10:20 am
Lecture Session 2
10:20 am-12:00 pm
- Phase II Trial Questions/Objectives
- Phase II Trial Designs
- Drug Combination Trials
- Multimodality Trials
Questions / Panel Discussion
Lunch
12:00 pm-1:30 pm
Protocol Development Group 2
1:30 pm-4:00 pm
Independent Study Time
4:00 pm-7:00 pm
Office Hours 1 (Biostatisticians and Patient Advocates; prescheduled appointments)
4:30 pm-6:30 pm
ASSIGNMENT DUE: PROTOCOL TEMPLATE
7:00 pm
Dinner
7:00 pm-9:00 pm
TUESDAY, JULY 25
Breakfast
7:00 am-8:00 am
Special Lecture
8:00 am-8:30 am
Lecture Session 3
8:30 am-10:00 am
- Feasibility and Reproducibility in Biomarker Studies
- Incorporation of Biological Correlative Studies into Early Clinical Trials
- Statistical Aspects of Correlative Studies
Questions / Panel Discussion
Break
10:00 am-10:30 am
Lecture Session 4
10:30 am-11:45 am
- Imaging in the Era of Targeted Therapy and Immunotherapy
- Special Considerations in the Design of Immunotherapy Studies
- Inflammatory and Immunologic Biomarkers
Questions / Panel Discussion
Lunch
11:45 am-12:45 pm
Protocol Development Group Session 3
12:45 pm-3:45 pm
Break
3:45 pm-4:00 pm
Office Hours 2: Protocol Related Questions
4:00 pm-6:00 pm
Independent Study Time
3:45 pm-7:00 pm
Pizza and salads available from 5:00 pm-7:00 pm
ASSIGNMENT DUE: STATISTICAL DESIGN
7:00 pm
WEDNESDAY, JULY 26
Breakfast
7:00 am-8:00 am
Small Group Discussion Sessions 1-3
8:00 am-9:00 am
- Elements of Artificial Intelligence
- Symptom Management, Patient Reported Outcomes, and Quality of Life
- Phase III Trials
Break
9:00 am-9:15 am
Small Group Discussion Sessions 4-6
9:15 am-10:15 am
- Navigating the National Clinical Trials Network
- Incorporation of Digital Health and PROs
- Laboratory Correlates
Break / Group Photo
10:15 am-10:45 am
Small Group Discussion Sessions 7-9
10:45 am-11:45 am
- Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints
- First in Human Trials: Understanding the Regulatory Process
- Large-Scale Genomic Analysis: Bench to Bedside
Lunch
11:45 am-12:30 pm
Protocol Development Group Session 4
12:30 pm-2:30 pm
Independent Study Time/Dinner on Own
2:30 pm-7:00 pm
ASSIGNMENT DUE: PROTOCOL DRAFTS
7:00 pm
THURSDAY, JULY 27
Breakfast
7:00 am-8:00 am
Lecture Session 5
8:00 am-9:40 am
- You’re In Charge: Investigator Responsibilities
- How to Pay For Your Trial
- Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study
- Community Engagement
Questions / Panel Discussion
Break
9:40 am-9:55 am
Lecture Session 6
9:55 am-11:35 am
- Data Collection: It’s All In the Data
- Inclusivity in Clinical Trials
Questions / Panel Discussion
Break
11:35 am-11:45 am
Keynote Lecture
11:45 am-12:35 pm
Lunch
12:35 pm-1:30 pm
Protocol Development Group Session 5
1:30 pm-3:00 pm
Independent Study Time/Dinner on Own
3:00 pm-7:00 pm
Office Hours 3
3:30 pm-5:00 pm
Optional Networking Session: Women in Hematology/Oncology
5:15 pm-6:15 pm
ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS
7:00 pm
FRIDAY, JULY 28
Breakfast
7:00 am-8:30 am
Faculty Meeting (Faculty Only)
7:30 am-8:30 am
Optional Career Sessions
(Exact topics to be determined based on accepted applicant interests, topics shown below are examples from past Workshops)
8:30 am-9:30 am
- Collaborating with Industry
- Careers in Radiation Oncology
- Career Transition Tips
Break
9:30 am-9:45 am
Lecture Session 7
9:45 am-11:10 am
- Successful Grantsmanship
- Reporting and Presenting Results
Questions / Panel Discussion
Break
11:10 am-11:20 pm
Protocol Development Group Session 6
11:20 am-1:00 pm
Lunch
1:00 pm-1:30 pm
Administration of Post-test
1:30 pm-2:30 pm
Independent Study Time
2:30 pm-7:00 pm
ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS
7:00 pm
Closing Reception / Banquet / Dance
7:00 pm-11:00 pm
SATURDAY, JULY 29
Continental Breakfast
5:00 am-8:00 am
Departure (on own)